PenBlade

Basic Information

• Brand Name: PenBlade
• Primary DI: 00618125190959
• Version / Model: PB-M-11P
• Catalog Number: PB-M-11P
• Company Name: TIDI PRODUCTS, LLC
• Labeler DUNS: 063519193
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-08
• Public Version: 1
• Public Version Date: 2024-01-16
• Public Version Status: New
• Public Device Record Key: 8dfee263-52a3-48d1-9264-8e75dcfda13e

Device Description

#11P Safety Scalpel, Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDX	Scalpel, One-Piece	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20618125190953	GS1	Shipper	10	In Commercial Distribution
Primary	00618125190959	GS1
Package	30618125190950	GS1	Overshipper	4	In Commercial Distribution
Previous	10853624005015	GS1
Package	10618125190956	GS1	Carton	10	In Commercial Distribution